MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1216

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Inappropriate or Unexpected Reset (2959)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330); Weight Changes (2607)

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that the patient experienced a buzzing, tingling sensation in her head and neck after a couple of minutes of charging her deep brain stimulation (dbs) implantable pulse generator (ipg).This painful sensation would build up until she could then feel them along the left side of her torso and left leg.On one occasion the patient received a jolt while charging.It was noted that the patient had gained some weight and the ipg was now more visible.The patient was advised on proper charging techniques and was provided a new charger.The patient later reported that they continue to have some symptoms, however this is at a much lesser level.The database analysis performed identified a bluetooth fault code when charging the ipg.Noise from the charging field of the charger interferes with the bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation.When the system resets, the stimulation momentarily turns off and then returns to normal operation.Engineers conclude that the patient could perceive the sudden change in stimulation as a feeling of overstimulation.No other anomalies were found with the analysis as the device displayed a normal charge log and all impedances were within the expected range.The ipg remains implanted in the patient and delivering therapy.

• Brand Name: VERCISE GENUS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18241646
• MDR Text Key: 330431402
• Report Number: 3006630150-2023-07462
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 561151
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female